Senior Clinical Research
Coordinator - SaMD

Kaliber is seeking a Senior Clinical Research Coordinator (Senior CRC) with the expertise and desire to join a rapidly growing company with an ambitious vision to transform surgical care to the benefit of patients and surgeons alike. The SeniorCRC will be responsible for managing all aspects of clinical operations, from study initiation to study completion and analysis, with rigorous attention to detail. The position will also oversee the research team’s compliance with both internal SOPs and FDA regulations. 


The ideal candidate demonstrates the ability to supervise clinical research staff, collaborate with external vendors, and succeed in a dynamic and fast-paced environment. Exceptional diplomacy, interpersonal and communication skills are essential, as is a high degree of integrity. Attention to detail and the ability to manage multiple responsibilities simultaneously are also critical attributes.

Responsibilities
 

  • Manages the full clinical study life cycle from initiation to completion.

  • Serves as primary contact and resource for assigned clinical studies and projects. 

  • Ensures studies are conducted per the protocol, GCP/ICH guidelines, FDA regulations, departmental SOPs, and DOPs.

  • ​​Proactively anticipates and understands potential concerns, issues, and delays in the process of each project and develops risk-assessment and contingency plans.

  • Provides comprehensive support for all operational aspects of assigned clinical studies, including the writing, review, and approval of protocols and study-related documents (e.g., Regulatory Binder, Study Plans, Case Report Forms, Informed Consent Templates, Monitoring Plans, and TMF).

  • Collaborates with internal cross-functional stakeholders, from R&D and Regulatory & Quality, and with
    external investigators and vendors to develop clinical studies, objectives, and study designs for clinical evidence generation.

  • Identifies issues and develops alternative solutions, which may include changes to programs, policies,
    and procedures.

  • Oversees the monitoring, implementation, and corrective actions for study progress using available study management tools.

  • Manages external vendors to ensure that deliverables are completed on time, within budget, and are consistent with the scope of work.

  • Manages the electronic data capture (EDC) system.

 

Qualifications
 

  • BA/BS (MA/MS preferred) and a minimum of 5 years of relevant medical device experience in conducting clinical studies.

  • Minimum of 3 years of experience in Clinical Research Coordination, Clinical Study Management, or
    equivalent roles.  

  • Exceptional subject matter expertise (medical device, software as medical device), as well as outstanding interpersonal and communication skills.

  • Ability to manage and shift priorities, handle numerous time-sensitive projects, and track multiple deadlines with high attention to detail and within set timelines.

  • Ability to accomplish goals by working creatively with other team members and by using “out of the box” thinking strategies.

  • Exceptional self-motivation and decision-making skills. 

  • Ability to work independently within a team.

  • Proficient interpersonal, written, and oral communication skills.

  • Strong working knowledge of Good Clinical Practice (GCP), FDA and ISO regulations, as well as current industry practices related to the conduct of clinical studies.

 

Location
 

Position is located at our Santa Clara, CA office. This role may also require visits to customer sites including medical facilities. Depending on the site's health and safety guidelines, you may be required to have medical screenings or vaccinations to meet site requirements, which may include Covid-19 vaccination and/or testing. 

 

Travel
 

Must be able to travel up to 15%

Benefits
 

  • Competitive compensation, Series B equity

  • Medical, dental, and vision insurance

  • Unlimited vacation

  • Opportunity to collaborate with world-renowned surgeons to help shape the future of surgery

Contact
 

To apply for this position, send your resume to jobs@kaliberlabs.com

About Kaliber Labs
Kaliber builds AI-powered solutions to meet the needs of patients, surgeons, and administrators in orthopedic surgery. Our intelligent software is designed to generate insights from surgical procedures—cut to close—and channel them into surgeon-centric tools to support quality, access, and cost of care. 
 

 

Kaliber Labs is an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.